15th Expert Committee on the Selection and Use of Essential Medicines

 

Secretariat proposed dosage form and strength review

 

Based on the review of the WHO Medicines Library website, carried out by the University of Liverpool, and further reviews by the Experts on the Committee, the Secretariat finally identified 6 entries on the Model List that do not have corresponding products, registered anywhere in the world. Proposed actions for the Committee are provided for each of them.

 

Aluminium acetate

No evidence of benefits has been identified for various skin conditions including suppurating superficial wounds and tropical ulcers, and the lesions produced by pemphigus and impetigo.

The trials identified by the Cochrane review (Macfadyen 2005) of topical antibiotics for chronically discharging ears with underlying eardrum perforations are small (Clayton 1990, Fradis 1997). The evidence is sparse. It suggests that aluminium acetate in the treatment of otorrhea is no worse than topical gentamicin or ciprofloxacin. Ciprofloxacin is on the Model List as an oral preparation. The Committee is requested to consider fast-track deletion.

 

Iopanoic acid

Currently oral cholecystography has been largely replaced with ultrasound diagnostic investigations. Contrast visualization technology might be required in rare complicated clinical situations to be performed by specialists. The general public health need therefore is not justified. The Committee is requested to consider fast-track deletion.

 

Neomycin/bacitracin

The trials identified by the Cochrane review (Koning 2003) are small. The evidence is sparse. It suggests that neomycin/bacitracin is no worse than chloramphenicol, less effective than topical fusidic acid or oral erythromycin for bullous impetigo, and is similar to fusidic acid for non-bullous empitigo. Fusidic acid is not on the Model List. Chloramphenicol and erythromycin are on the Model list as preparations for systemic use. The Committee is requested to consider if fast-track deletion is appropriate.

 

Nifurtimox

The existing sparse evidence from a Cochrane systematic review (Villar 2002) suggests that trypanocidal therapy, particularly nitroimidazolic derivatives given to asymptomatic children or adults with positive xenodiagnosis (chronic asymptomatic Trypanosoma cruzi infection) improve parasite-related outcomes. No data for clinical outcomes are available.

In late stage symptomatic Chagas disease parasitologic cure rates were found to be similar with nifurmitox treatment and placebo, without benefits for clinical symptoms, as shown in the only RCT (Rodriguez Coura) identified by a Cochrane review (Reyes 2005). In view of the major public health importance of Chagas disease the Committee is requested to consider retaining nifurtimox on the Model List.

 

Propyliodone

No evidence identified to date. Not available in any of the world's market. Used only for bonchograms which are now generally obsolete. Specialist expertise is required for safe use of propyliodone. The Committee is requested to consider fast-track deletion.

 

Triclabendazole

The identified recent trials of triclabendazole for fascioliasis and paragonimiasis are open, not all of them are randomized, there is no control with alternative comparators: Navo-Ocampo 2004, Calvopina 2003, el-Morshedy 1999 . Nonetheless the results of these trials suggest that triclabendazole in the treatment of fascioliasis and paragonimiasis is effective and well tolerated. In view of the major public health importance of fascioliasis and paragonimiasis the Committee is requested to consider retaining triclabendazole on the Model List.

 

References:

Macfadyen CA, Acuin JM, Gamble C. Topical antibiotics without steroids for chronically discharging ears with underlying eardrum perforations. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD004618. DOI: 10.1002/14651858.CD004618.pub2.

Clayton MI, et al. A double-blind, randomized, prospective trial of a topical antiseptic versus a topical antibiotic in the treatment of otorrhea. Clinical Otolaryngology and Allied Sciences 1990 Feb;15(1):7-10.

Fradis M, Brodsky A, Ben-David J, Srugo I, Larboni J, Podoshin L. Chronic otitis media treated topically with ciprofloxacin or tobramycin. Archives of Otolaryngology - Head and Neck Surgery 1997 Oct;123(10):1057-60.

Koning S, et al. Interventions for impetigo. Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD003261. DOI: 1002/14651858.CD003261.pub2.

Nava-Ocampo D, et al. Randomized trial of a single, double and triple dose of 10 mg/kg of a human formulation of triclabendazole in patients with fascioliasis. Clinical and experimental pharmacology & physiology. 2004 Nov, V31, 11, P. 777-82.

Calvopina M, et al. Comparison of two single-day regimens of triclabendazole for the treatment of human pulmonary paragonimiasis. Transactions of the Royal Society of Tropical Medicine and Hygiene. 2003 Jul-Aug, V 97: 4, 451-4.

el-Morshedy H, et al. Triclabendazole in the treatment of human fascioliasis: a community-based study. Eastern Mediterranean health journal 1999 Sep, V 5: 5, 888-94.

Villar JC, et al. Trypanocidal drugs for chronic asymptomatic Trypanosoma cruzi infection. Cochrane Database of Systematic Reviews 2002, Issue 1. Art. No.: CD003463. DOI: 10.1002/14651858.CD003463.

Rodriguez Coura J, et al. A controlled comparative study using benznidazole, nifurtimox and placebo in chronic Chaga's disease patients, in a field area with interrupted transmission: I. preliminary evaluation [Estudo comparativo controlado com emprego de benznidazole, nifurtimox e placebo, na forma cr?ica da doen? de Chagas, em uma ?ea de campo com transmiss? interrompida: I. avalia?o preliminar]. Revista da Sociedade Brasileira de Medicina Tropical 1997;30:139-44.

Reyes PA, Vallejo M. Trypanocidal drugs for late stage, symptomatic Chagas disease (Trypanosoma cruzi infection). Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD004102. DOI: 10.1002/14651858.CD004102.pub2. H Ejere, E Schwartz, R Wormald. Ivermectin for onchocercal eye disease (river blindness). Cochrane Database of Systematic Reviews 2001, Issue 2. Art. No.: CD002219. DOI: 10.1002/14651858.CD002219.

 

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Last update:12-Mar-2007